Dietary ModificationBeefNCT02675348
Beef Protein Supplementation in Endurance Athletes
A study testing Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO in people with Dietary Modification, run by University of Greenwich at 1 site in United Kingdom.
Trial summary
The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- regularly trained endurance athletes,
- aged 30 to 60 years old,
- minimum 2 years of experience,
- volunteers,
Who cannot join
- any musculoskeletal injuries, metabolic conditions, or diseases;
- use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Life and Sports Science
Chatham, Kent, ME4 4TB
About this study
Official title: Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure, Immunological and Haematological Markers in Endurance Athletes
The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates beef protein extract compared to the ingestion of others commercially available protein sources such as whey and non protein only carbohydrate contrast nutrients.
Read the detailed description
This investigation involves a 10 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates beef protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, body composition and blood markers after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (Beef); 2) Whey (Whey) and 3) non-protein iso-energetic placebo (CHO).
Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: Beef; Whey and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the three specific supplementation treatments (Beef, Whey or CHO). Measurements of blood, body composition, muscle structure and endurance performance will be determined before and after the training intervention.
Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance (Vo2max). 1) The Beef protein group (Beef n=12) that will take 20g of hydrolysates beef protein powder and 250 ml of water 2) The whey group (n=12) will take 20 g of whey intact isolate powder mixed with 250 ml of water 3) the contrast group (CHO n=12) that will take an iso-energetic non-protein, only carbohydrate (20 f of maltodextrin plus 250 ml of water) contrast.
Participants: Thirty six participants, recruited from Kent, Medway University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.
Intervention Familiarization period: Participants will undertake 1 sessions of familiarisation with the testing procedure. A qualified conditioning coach will control and assists participants in order to guarantee a correct understanding of the assessment procedure (Body composition, vo2max test, muscle thickness, etc). All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (6-20) Borg scale and the heart rate monitor to control the load and training intensity during test and training.
Endurance Training: Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [≥ the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax] (Esteve-Lanao et al., 2007). Participants will train 4 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.
Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast.
Supplements and placebo will be provided in powder form and should be mixed with 250 ml of plain water at the moment of consumption. Supplements and placebo will looks and tastes identical.
Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 70 doses for a total of 10 weeks of study intervention.
Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.
- Conditions
- Dietary Modification
- Being tested
- Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein, Dietary Supplement: CHO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Beef ProteinDietary supplement
Also called 100% all beef
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
Dietary Supplement: whey ProteinDietary supplement
Also called Whey protein powder
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
Dietary Supplement: CHODietary supplement
Also called maltodextrin
Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Beef Protein | Experimental | All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min.
Intervention will last for 10 weeks. Participants will ingest 20g of beef protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). Receives: Dietary Supplement: Dietary Supplement: Beef Protein |
| Dietary Supplement: Whey Protein | Experimental | All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min.
Intervention will last for 10 weeks. Participants will ingest 20g of whey protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). Receives: Dietary Supplement: Dietary Supplement: whey Protein |
| Dietary Supplement: CHO | Active comparator | All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min.
Intervention will last for 10 weeks. Participants will ingest 20g of maltodextrin powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). Receives: Dietary Supplement: Dietary Supplement: CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fat-Free mass
Measured: 10 weeks
Body composition
Fat mass
Measured: 10 Weeks
Muscular thickness
vastus medialis thickness
Measured: 10 weeks
Endurance Performance
Vo2max
Measured: 10 weeks
Endurance Performance
Ventilatory threshold 2
Measured: 10 Weeks
Blood Markers
haemoglobin
Measured: 10 weeks
Blood Markers
red blood cell
Measured: 10 weeks
Blood Markers
haematocrit
Measured: 10 weeks
Blood Markers
transferrin
Measured: 10 weeks
Secondary outcomes (3)
Immunology markers
neutrophils
Measured: 10 weeks
Immunology markers
lymphocyte
Measured: 10 weeks
Immunology markers
monocytes
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Fernando Naclerio, Ph D, Study director, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675348
- Sponsor's protocol ID
- fES-uREC-15-1 3 02
- Acronym
- Beef
- Status last verified
- May 2017
- First submitted
- 2 Feb 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meat Protein Administration on Body Composition, Strength, Muscle Structure, Immunological and Haematological Markers in Endurance Athletes
- ClinicalTrials.gov ID
- NCT02675348
- Acronym / sponsor ID
- Beef / fES-uREC-15-1 3 02
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to investigate the potential benefits of combining a new protein beef hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) blood markers of health in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates beef protein extract compared to the ingestion of others commercially available protein sources such as whey and non protein only carbohydrate contrast nutrients.
Detailed description
This investigation involves a 10 weeks randomised, balanced, double blind parallel group between-subjects design aimed to analyse the effects of combining exercise and a post exercise nutrition strategy (hydrolysates beef protein, whey protein or a isocaloric only carbohydrate placebo) on training outcomes, body composition and blood markers after a period of regular training and feeding intervention. Participants will be divided in three-treatment groups 1) Hydrolysed meat-protein (Beef); 2) Whey (Whey) and 3) non-protein iso-energetic placebo (CHO).
Once considered eligible for the study, and after an initial familiarisation period and baseline tests, participants will be randomly assigned to one of the intervention groups: Beef; Whey and CHO. Each group will follow a 10-week periodised endurance training intervention combined with one of the three specific supplementation treatments (Beef, Whey or CHO). Measurements of blood, body composition, muscle structure and endurance performance will be determined before and after the training intervention.
Once informed consent and health history have been obtained, after the baseline Assessment (t1), participants will divided into three similar profile groups, matched by body mass, age, sex and performance (Vo2max). 1) The Beef protein group (Beef n=12) that will take 20g of hydrolysates beef protein powder and 250 ml of water 2) The whey group (n=12) will take 20 g of whey intact isolate powder mixed with 250 ml of water 3) the contrast group (CHO n=12) that will take an iso-energetic non-protein, only carbohydrate (20 f of maltodextrin plus 250 ml of water) contrast.
Participants: Thirty six participants, recruited from Kent, Medway University Campus, will take part in the project. After being informed of all risk, discomforts, and benefits involved, participants will sign a written informed consent regarding their participation.
Intervention Familiarization period: Participants will undertake 1 sessions of familiarisation with the testing procedure. A qualified conditioning coach will control and assists participants in order to guarantee a correct understanding of the assessment procedure (Body composition, vo2max test, muscle thickness, etc). All participants will be instructed about the appropriate use of the Rate of Perceived Exertion (6-20) Borg scale and the heart rate monitor to control the load and training intensity during test and training.
Endurance Training: Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [≥ the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax] (Esteve-Lanao et al., 2007). Participants will train 4 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity.
Supplementation protocol: Training days: Immediately (<10 min) after com Non-training days: before breakfast.
Supplements and placebo will be provided in powder form and should be mixed with 250 ml of plain water at the moment of consumption. Supplements and placebo will looks and tastes identical.
Thus, a total of one 20g doses will be administered on daily bases. Participants should ingest a total of 70 doses for a total of 10 weeks of study intervention.
Supplement will be provided in 14 days based by a blind researcher after Participants should return back the empty bag of the supplement/placebo consumed during the previous 14 days period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Beef Protein | Experimental | Dietary Supplement: Dietary Supplement: Beef ProteinAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of beef protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
| Dietary Supplement: Whey Protein | Experimental | Dietary Supplement: Dietary Supplement: whey ProteinAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of whey protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
| Dietary Supplement: CHO | Active comparator | Dietary Supplement: Dietary Supplement: CHOAll the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of maltodextrin powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- regularly trained endurance athletes,
- aged 30 to 60 years old,
- minimum 2 years of experience,
- volunteers,
Key exclusion criteria (2 listed)
- any musculoskeletal injuries, metabolic conditions, or diseases;
- use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: Beef ProteinAlso: 100% all beefParticipants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes | Dietary supplement | Dietary Supplement: Beef Protein |
| Dietary Supplement: whey ProteinAlso: Whey protein powderParticipants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes | Dietary supplement | Dietary Supplement: Whey Protein |
| Dietary Supplement: CHOAlso: maltodextrinParticipants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes | Dietary supplement | Dietary Supplement: CHO |
Primary outcome
Body composition
Time frame: 10 weeks
Fat-Free mass
Body composition
Time frame: 10 Weeks
Fat mass
Muscular thickness
Time frame: 10 weeks
vastus medialis thickness
Endurance Performance
Time frame: 10 weeks
Vo2max
Endurance Performance
Time frame: 10 Weeks
Ventilatory threshold 2
Blood Markers
Time frame: 10 weeks
haemoglobin
Blood Markers
Time frame: 10 weeks
red blood cell
Blood Markers
Time frame: 10 weeks
haematocrit
Blood Markers
Time frame: 10 weeks
transferrin
3 secondary outcomes
Immunology markers
Time frame: 10 weeks
Immunology markers
Time frame: 10 weeks
Immunology markers
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Naclerio, Ph D study director
University of Greenwich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Beef Protein, Dietary Supplement: whey Protein and Dietary Supplement: CHO in people with Dietary Modification, run by University of Greenwich at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.